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Principal Site Contract Lead. (Poland) Sponsor dedicated. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities
Perform and manage all activities associated with developing and negotiating R&D site contracts, including company sponsored and investigator sponsored clinical site contracts, nonclinical contracts, confidentiality disclosure agreements, and cooperative research agreements. Responsible for timely delivery of R&D site agreements that protect the sponsor business interests and compliance with regulations and laws concerning the same including compliance with Fair Market Value (“FMV”).
Advise study teams on the country specific characteristics related to site contracts, for the client sponsored study of any complexity, including contribution to site selection process and site prioritization activities;
Supporting asLead Contract Manager, one point of contact for multiple studies
Prepare, distribute, negotiate, and drive to execution site contracts Clinical Trial/Study Agreements or Study Letter if Master Agreement is in place) with the appointed Clinical Research Organization (“CRO”) or affiliate or directly with the site as appropriate
Escalate to appropriate sponsor colleague when a significant risk to the business is identified
Independently make appropriate business decisions within their scope of authority and educate internal project leaders on the issues and risks associated with contracting and/or budget decisions.
Ensure that clinical contracts are negotiated within the Fair Market Value in accordance to guidelines and SOPs.
Identify potential risks and manage issue resolution ofhigh complexity.
Ensures status reports are provided to appropriate parties both internally and externally on a regular basis.
Evaluate changes, identify business and/or legal risk associated with such changes and escalate relevant requests to either legal and/or business partners and/or line managers as appropriate proposing alternative solutions or feedback to facilitate the review.
Evaluate changes requested within contracts, identify business and/or legal risk associated with such changes and escalate relevant requests to either legal team leads and/or business partners and/or line managers as appropriate proposing alternative solutions or feedback, whenever possible, to facilitate the review.
Participate in the drafting and/or revision of the contract templates, when necessary, escalating to legal team leads.
Escalate issues when needed and encourage resolution at the lowest appropriate level.
Drive department specific initiatives and projects regionally or globally
Create back-up and or mitigation plans in order to get in front of potential specific risks within the department
Requires minimal supervision
Capitalize on strengths of relationships/networks to effectively work with cross functional teams and influence these teams as necessary
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.